US FDA Exploring Options To Improve Study Of Drugs In Elderly
Executive Summary
New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.
You may also be interested in...
Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment
US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.
Real-World Data Of Cancer Drugs In Elderly Could Push Regulators Toward Broader Trial Eligibility
Medicare patients fared worse than pivotal trial populations on cancer drugs, two recent papers conclude, offering more ammunition for an increased regulatory focus on more generalizable trial populations. Current drug labels may portray an inaccurate risk-benefit calculation in older populations, which account for most cancer cases.